Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Metaplasia

Stomach Cancer

Get pictures and Videos from gastric antrum body and angle by confocal laser endomicroscopy in order to calculate the CGGIM score.

Get pictures and Videos from gastric antrum body and angle by Artificial intelligence in order to calculate the CGGIM score.

Yanqing Li, MD, PhD

Rui Ji, MD, PhD

Yanqing Li, MD. PhD.

Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies.

Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies. The investigators aim to design the CGGIM scores to evaluate gastric cancer risk.

When a gastric mucosal lesion is found using confocal laser microendoscopy, endoscopist will take biopsy for histology examination. In addition, random biopsies to ensure at least four biopsies from the gastric antrum and body to cauculate the OLGIM

Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.

Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk: a Prospective Exploratory Study

The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated to be compared with OLGIM based on the results of the endoscopist 's procedure.

The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated based on existing AI model identification results and compared with OLGIM.

Chi-square test was used to compare the accuracy of endoscopists and AI in the diagnosis of OLGIM

Shandong University

Vice President of Qilu Hospital

Infections

Communicable Diseases

Atrophy

Gastritis, Atrophic

Precancerous Conditions

Gastritis

Gastrointestinal Diseases

Stomach Diseases

Gastroenteritis

Subjects with histologically-confirmed intestinal metaplasia found during endoscopy with protocoled biopsies.

Subjects without intestinal metaplasia found during endoscopy with protocoled biopsies (age and sex matched to cases)

Robert J Huang, MD

Joo Ha Hwang, MD, PhD

Gastric cancer afflicts 27,000 Americans annually and carries a dismal prognosis. One reason for poor outcomes is late diagnosis, as the majority of gastric cancers in the United States are diagnosed at a relatively advanced stage where curative resection is unlikely. Gastric intestinal metaplasia (GIM) is a precancerous change of the stomach which increases risk for subsequent gastric cancer multiple-fold.

The Gastric Precancerous Conditions Study (GAPS) is an observational study with two over-arching objectives: 1) improve the non-invasive identification of patients with GIM, and 2) develop biological markers to predict the subset of GIM which will progress onto gastric cancer.

To achieve Aim 1, a case-control study (N=300 pairs) matching cases of GIM with age-/gender-matched controls will be recruited form the population of subjects undergoing clinically-indicated endoscopy. Determination of gastric pathology will be made by two, independent gastrointestinal pathologists. At time of endoscopy, a detailed clinical questionnaire is administered by face-to-face interview. Saliva and blood is collected prior to endoscopy. At time of endoscopy, protocoled clinical biopsies (per Revised Sydney Protocol) as well as additional research specimens are collected. Scoring of GIM will be performed based on the Operative Link for GIM scoring system.

To achieve Aim 2, patients with histologically-confirmed GIM (N=300) will be followed longitudinally. Biennial endoscopic surveillance will be performed, with repeat biopsies, specimen collection, and histologic scoring. Progression of GIM will be defined as upstaging of GIM score, or development of either dysplasia or carcinoma on any biopsy.

The GAstric Precancerous Conditions Study

Progression will be assessed using the Operative Link for Gastric Intestinal Metaplasia (Reference 1). This score reflects both the histologic severity as well as anatomic location of intestinal metaplasia. Scores range from 0 (no metaplasia) to 4 (severe metaplasia). It is believed that higher scores portend a higher risk for progression to cancer.

Stanford University

Instructor of Medicine, Principal Investigator

Following routine endoscopic evaluation, investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment.

Mucosal Irrigation

Monika Laszkowska, MD

Charles Lightdale, MD

This will be a pilot study investigating the feasibility of using pressurized irrigation of the stomach mucosa to obtain gastric aspirate cell samples for analysis and identification of premalignant lesions of the stomach.

Gastric cancer is an important public health concern, accounting for 26,240 new cases in the United States (US) annually. Outcomes are poor, with 5-year survival of 31%, but improve when lesions are detected at early stages amenable to curative therapy. Research has shown that lesions such as atrophic gastritis and gastric intestinal metaplasia are precursors to more advanced lesions such as dysplasia and adenocarcinoma, thus providing a potential target for early intervention. Gastric cancer screening programs have decreased mortality in high-prevalence countries like Japan. However, providers in low-prevalence settings are less experienced at detecting precursor lesions endoscopically on visual inspection. This pilot study will investigate a novel approach to screening for precursor lesions and early detection of gastric cancer by utilizing pressurized irrigation of the gastric mucosa. The study will target patients with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy. Following routine endoscopic evaluation, the investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment. The goal is that this technique will simplify testing for precursor lesions of gastric cancer, making screening more effective in regions of lower prevalence where providers are less experienced with visual identification of such lesions.

This is a pilot feasibility study. High-risk individuals with known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, dysplasia) who are presenting for routine surveillance endoscopy will undergo mucosal irrigation and collection of gastric aspirate for analysis, in addition to standard of care (visual inspection on endoscopy).

Novel Approach to Surveillance of Gastric Lesions

A Novel Approach to the Surveillance of Pre-Malignant Gastric Lesions

Investigators will compare how the diagnosis determined from pathologic/cytologic analysis gastric aspirate samples will compare with diagnosis obtained from standard endoscopic inspection and biopsies. The diagnoses of interest will be normal mucosa, atrophic gastritis, intestinal metaplasia, dysplasia, or malignancy. This will be reported as the percentage of concordant diagnoses.

New York Presbyterian Hospital

Principal Investigator

Soo-Jeong Cho, MD, PhD

In this study, we aim to establish a prospective cohort of patients with endoscopically and histologically confirmed intestinal metaplasia, collect gastric mucosal tissue samples from this cohort, and follow the development of gastric cancer over time.

Patients visiting Seoul National University Hospital, who have previously received an incidental diagnosis of intestinal metaplasia during a prior gastroscopy examination, will be considered as potential candidates for this study. Upon obtaining their informed consent to participate, the initial endoscopy procedure will involve the collection of biopsies to ensure an accurate histological diagnosis of intestinal metaplasia. These biopsies will be taken from the antrum and body of the stomach, according to the protocol of the updated Sydney system, to pathologically diagnose the extent and severity of intestinal metaplasia. One to two pieces of tissue remaining from this diagnostic process will be retained for future analysis. Subsequently, patients will be followed up on an outpatient basis to track the development of gastric cancer through routine screening endoscopies. In cases where patients develop gastric cancer, a comparative analysis will be conducted with those who do not develop gastric cancer, to determine the differences in expression of markers in the gastric mucosal tissue that was collected during the initial endoscopy. Our ultimate aim is to identify potential biomarkers that may serve as predictive indicators for the development of gastric cancer in patients with a preexisting diagnosis of intestinal metaplasia.

Gastric mucosal tissue from the antrum and body of the stomach

Intestinal Metaplasia Cohort for Gastric Cancer Prediction

A Prospective Cohort Study for Gastric Cancer Prediction in Patients With Intestinal Metaplasia

Number of Participants Who Develop Gastric Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.	NCT05459428	Intestinal Meta... Confocal Laser ...		40 Years - 80 Years	Shandong University
The GAstric Precancerous Conditions Study	NCT04191551	Gastric Cancer Intestinal Meta... Helicobacter Py... Atrophic Gastri...		35 Years - 84 Years	Stanford University
Novel Approach to Surveillance of Gastric Lesions	NCT04251403	Intestinal Meta... Gastric Dysplas... Gastric Cancer Atrophic Gastri...	Mucosal Irrigat...	18 Years -	New York Presbyterian Hospital
Novel Approach to Surveillance of Gastric Lesions	NCT04251403	Intestinal Meta... Gastric Dysplas... Gastric Cancer Atrophic Gastri...	Mucosal Irrigat...	18 Years -	New York Presbyterian Hospital
Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.	NCT05459428	Intestinal Meta... Confocal Laser ...		40 Years - 80 Years	Shandong University
Intestinal Metaplasia Cohort for Gastric Cancer Prediction	NCT06075199	Intestinal Meta...		18 Years -	Seoul National University Hospital

Spots Global Cancer Trial Database for intestinal metaplasia of gastric mucosa